Known bladder endoprostheses comprise a balloon casing made with an impermeable layered silicone membrane covered with a layer made of biocompatible and biodegradable material. According what is known, the biocompatible and biodegradable covering material is a fabric made of PGA fiber.
The casing is sufficiently rigid so as to stably keep its shape and flexible such that it can be manually compressed to ensure that it empties.
The casing has a connection element located at a lower portion of the casing to connect with the patient's urethra. Similarly, two connection bodies are located at the top to enable connection with the ureters.
The connection bodies are also covered with the biodegradable material.
Following the implant of the endoprosthesis in the patient, there is the formation of a musculo-fibrous tissue layer or fibrous capsule (not impermeable) around the covering of the casing, while the biodegradable material decomposes. In such a manner, a neobladder is generated around the endoprosthesis.
During the resorption, there is the formation of a transition epithelium layer, which is also called urothelium, which is advantageously impermeable. This is essential for ensuring the correct functioning of the prosthesis and of the neobladder that is being formed.
The obtainment of this type of endoprosthesis is complex and costly.
Indeed, the covering made of biocompatible and biodegradable material must be obtained in order to fit on the silicon casing.
In fact, extreme precision is necessary for the correct relative sizing of casing and covering. It is known that the covering also covers the connectors.
This renders the obtainment complex, long and costly.
Other known solution as, for example, in WO2014/057444 discloses an orthotopic artificial bladder endoprosthesis comprising a cuff substantially rigid and shaped as a balloon and comprising an inner surface and an outer surface defining a space suitable for the containment of the urine; according to said solution the rigidity of the cuff and their stable and extended position is obtained by using layers of material made of multilayered silicone suitable for obtaining a cuff sufficiently rigid so as to maintain a balloon shape and, at same time, sufficiently flexible so as to allow deformation caused by external pressure aimed to drain the bladder itself.
Another solution is disclosed in WO98/50100 as a device suitable for feeding an under pressure fluid inside a balloon inserted in a body chamber and aimed to allow and cause a tissue expansion of said cavity affected by a pathology.
Other known documents, such as WO2007/075545, disclose a catheter or a device to drain liquid from a body cavity or from a cavity obtained by surgery, with said device comprising a shaft, an expandable balloon connected to an end of the shaft, a permeable layer arranged outside the expandable balloon and with the shaft comprising a duct discharging the drainage liquid and also comprising a duct for feeding under pressure fluid in the balloon so as to inflate said balloon.
Another document, U.S. Pat. No. 4,219,026, discloses a bladder hemostatic catheter having an elongated shaft provided with a duct or lumen extending along the shaft and also comprising an inflatable balloon made of elastic material covering the distal end of the shaft and with said balloon that when inflated takes a substantially spherical shape suitable to fill the bladder and to exert the pressure requested for terminating the hemorrhages.
An artificial bladder prosthesis in disclosed also in FR2759575 as comprising a containment element made of a double layered material comprising an inner layer and an outer layer made of different materials and with said different material suitable for allowing the implant of the containment element in the patient body avoiding transplant rejection and avoiding drawbacks related to the fact that the urine in the containment element can damage the containment element itself and, furthermore, said double layered material id realized with the aim to keep the rigid shape of the containment element itself.
Another artificial bladder is disclosed in WO2007/095193, as defined by a structure comprising two hemispherical portions joined one to the other and provided with outer flanges suitable for allowing a manipulation of said portions prior or during the surgery and also for allowing the connection of said two portions.
All the known solutions for bladder prosthesis are complex under a constructional point of view, the implant or surgery and so on and, as a consequence, they are costly.